Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.
NCT04229264
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Written informed consent.
- Age>18 years old.
- Negative serum pregnancy test (in women of childbearing only).
- Patients submitted to endovascular procedures below-the-knee by not exclusively.
- Patient understands and is willing and able to comply with the study instructions and follow-up visit.
- More than 70% stenosis or occlusion of the three distal arteries including or not the tibiofibular trunk (TFT).
- Tissue loss (Rutherford 5).
- One or more patent vessel of pedal arch.
- TASC II D femoral and/or popliteal occlusion.
- Life expectancy less than 1 year.
- Allergy or contraindication to apixaban treatment.
- Allergy or contraindication to dual antiplatelet treatment.
- Creatinine clearance less than 30mL/min.
- Planned major amputation before procedure.
- Hybrid procedure (open and endovascular).
- Use of fibrinolytic in the past 10 days.
- Known HIV infection.
- Liver disease (acute or chronic hepatitis and cirrhosis).
- Drug addiction or alcohol abuse 12 months before the randomization.
- Concomitant medications thatinhibit the CYP 3A4 cytochrome and P glycoprotein
(ketoconazole, Iitraconazole, ritonavir).
- Platelets count inferior to 100x109/L.
- INR more than 1.5.
- History or condition with high risk of bleeding: Eg. Trauma within 30 days before
randomization, gastrointestinal bleeding 6 month before the randomization,
intra-ocular, spinal, intra-articular bleeding (any time before), AV malformation,
cerebral aneurysm and hypertension without control.
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